MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOLD FIBERED DETACHABLE COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83910
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Stretched (1601); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil malpositioned.An 8mm x 20cm embold fibered detachable coil system was selected for use in an aneurysm bleed.The pseudoaneurysm was off the common hepatic artery.This was the sixth coil of the procedure.The physician did not like how the coil was coming out of the catheter, so an attempt was made to retrieve the coil into the catheter, but the coil stretched.There was no attempt to deliver the coil, but the coil detached in the catheter; the proximal release perforation was not broken.The coil was in the intended common hepatic artery, but when the coil stretched, it ended up moving into the celiac artery with the stretched portion extending into the aorta.No portion of the coil remained in the target location.No patient complications were reported.
Event or Problem Description
It was reported that the coil malpositioned.An 8mm x 20cm embold fibered detachable coil system was selected for use in an aneurysm bleed.The pseudoaneurysm was off the common hepatic artery.This was the sixth coil of the procedure.The physician did not like how the coil was coming out of the catheter, so an attempt was made to retrieve the coil into the catheter, but the coil stretched.There was no attempt to deliver the coil, but the coil detached in the catheter; the proximal release perforation was not broken.The coil was in the intended common hepatic artery, but when the coil stretched, it ended up moving into the celiac artery with the stretched portion extending into the aorta.No portion of the coil remained in the target location.No patient complications were reported.It was further reported that the coil stretched when they tried to pull it back into the sheath, and the coil eventually broke.

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20173905
• Report Number: 2124215-2024-56134
• Device Sequence Number: 8069831
• Product Code: KRD
• UDI-Device Identifier: 08714729983620
• UDI-Public: 08714729983620
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0034021205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/02/2024
• Date Device Manufactured: 05/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown